A Randomised, Open-label, Phase III Study to Evaluate the Efficacy and Safety of Oral Afatinib (BIBW 2992) Versus Intravenous Methotrexate in Patients With Recurrent and/or Metastatic Head and Neck Squamous Cell Carcinoma Who Have Progressed After Platinum-based Therapy

CompletadoFase 3ClinicalTrials.gov

ID: NCT01345682Tipo: INTERVENTIONALInicio: 5 de ene de 2012Fin estimado: 6 de dic de 2016

Traducción no disponible, mostrando original

Resumen

This randomised, open-label, phase III study will be performed in patients with R/M head and neck squamous cell carcinoma (HNSCC) who have progressed after platinum-based therapy. The objectives of the trial are to compare the efficacy and safety of afatinib versus methotrexate

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Histologically or cytologically confirmed R/M HNSCC of the oral cavity, oropharynx, hypopharynx or larynx, not amenable for salvage surgery or radiotherapy
Documented progressive disease based on investigator assessment according to Response Evaluation Criteria in Solid Tumours (RECIST) following receipt of at least two cycles of cisplatin or carboplatin administered for R/M disease
Measurable disease according to RECIST
Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

Criterios de exclusión

Progressive disease within three months of completion of curatively intended treatment for locoregionally advanced or metastatic HNSCC
Any other than one previous platinum based systemic regimen given for R/M disease
Prior treatment with epidermal growth factor receptor (EGFR)-targeted small molecules
Pregnancy or breast feeding

Intervenciones

drug

Afatinib

Once daily

drug

Methotrexate

Weekly

Ubicaciones

1200.43.05401 Boehringer Ingelheim Investigational Site

Ciudad Autonoma de Bs As, Argentina

1200.43.05402 Boehringer Ingelheim Investigational Site

Santa Fe, Argentina

1200.43.05403 Boehringer Ingelheim Investigational Site

Villa Domínico, Argentina

Patrocinadores

PrincipalBoehringer Ingelheim

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